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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040631
Receipt No. R000046344
Scientific Title Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Date of disclosure of the study information 2020/06/02
Last modified on 2020/06/02

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Basic information
Public title Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Acronym Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes;Urine metabolomics in patients with diabetic neuropathy
Scientific Title:Acronym Clinical significance of serum chemokine levels (CCL11 / CCL22 / TARC) in patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we targeted patients with type 2 diabetes by measuring CCL11 (eotaxin) and CCL22 (MDC), one of the chemokines, and IL-6 and IL-18, which are one of the cytokines. The purpose of this study is to analyze the clinical significance of the three major complications of patients with diabetic neuropathy, insulin resistance, arteriosclerosis, and other blood sampling . In addition, urinary metabolomics and urinary NGAL are measured, the relationship with diabetic neuropathy is considered, and the aim is to search for new clinical markers that are considered necessary for future treatment of diabetic neuropathy.
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to analyze the clinical significance of the three major complications mainly of diabetic neuropathy, insulin resistance, arteriosclerosis, and various blood sampling items in type 2 diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical significance of serum chemokine levels in patient with diabetes and diabetic neuropathy.
Key secondary outcomes Time of measurement: early in the morning, fasting
Measurement items (LSI): CCL11 (eotaxin) CCL22 (MDC)
IL-6 IL-18
Urine Metabolomics
U-NGAL
serum: FGF21 BDNF HMW adiponectin IL-33s TNF-R1 & -R2

Relationship with diabetic complications: peripheral neuropathy: staging, nerve conduction test, CVR-R
Orthostatic hypotension (Sheron test)
Timed up and Go test, Monofilament
Nephropathy: eGFR UAE
Retinopathy: Stage

Relationship with insulin resistance: BMI, InBody, DualScan
Relationship with arteriosclerosis: CAVI / ABI FMD carotid IMT
Routine examination at admission + IgE + TARC + Beta-hydroxyl-butyrate + M2BPG (i Mac-2 binding protein sugar chain modification isomer), Ca, P, active Vitamin D3

Heart rate variability (HRV): CVR-R, power spectrum analysis (PSA)
The severity of diabetic kidney disease
Coagulation fibrinolysis system: vWF, d dimer, etc.
Arterial stiffness: PWV, CAVI
abdominal echo

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 and 12.0%) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria 1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Patient with intolerance of medical reasons by doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Teruo
Middle name
Last name Jojima
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code 321-0293
Address 880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0828-87-2150
Email jojima@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Teruo
Middle name
Last name Jojima
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code 321-0293
Address 880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0282-87-2150
Homepage URL
Email jojima@dokkyomed.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism,
Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dokkyo Medical University
Address 880kita-kobayashi,Mibu,Tochigi,Japan
Tel 0282-87-2275
Email r-kenkyu@dokkyomed.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cross section study

Management information
Registered date
2020 Year 06 Month 02 Day
Last modified on
2020 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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